DIABETIC SILTUSSIN DM DAS-NA- guaifenesin and dextromethorphan hydrobromide liquid

Diabetic Siltussin DM DAS-Na by

Drug Labeling and Warnings

Diabetic Siltussin DM DAS-Na by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoonful)(TSP))

Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL (teaspoonful)(TSP))

PURPOSE

Purpose of Guaifenesin: Expectorant

Purpose of Dextromethorphan Hydrobromide: Cough Suppressant

INDICATIONS & USAGE

Uses

■ temporarily relieves cough due to minor throat and bronchial irritation
■ helps loosen phlegm (mucus)
■ thin bronchial secretions to make coughs more productive

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

■ persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
■ cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

■ cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition
■ hypersensitive to any ingredients

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take every 4 hours, or as directed by a doctor, and not more than 6 doses in 24 hours. This adult product is not intended for use in children under 12 years of age.

• Adult and children 12 years and over:

  2 teaspoonfuls (TSP);

• Children under 12 years:

  DO NOT USE

Other information
■ store at room temperature 20°-25°C (68° - 77°F)
■ Phenylketonurics: contains phenylalanine 3 mg per teaspoonful (5 mL)

Inactive ingredients

Acesulfame-K, aspartame, benzoic acid, hydroxypropyl methyl cellulose, methylparaben, propylene glycol, strawberry flavor, and water. May contain citric acid.

Questions

888-974-5279

Manufactured by:

Silarx Pharmaceuticals, Inc
1033 Stoneleigh Ave.
Carmel, NY 10512
USA

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIABETIC SILTUSSIN DM DAS-NA 
guaifenesin and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-6760(NDC:54838-139)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
acesulfame potassium (UNII: 23OV73Q5G9)
aspartame (UNII: Z0H242BBR1)
benzoic acid (UNII: 8SKN0B0MIM)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
anhydrous citric acid (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (strawberry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-6760-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/24/2012

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc.		791119022	RELABEL(68788-6760)